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<h2>Program Lead/Presenter: Paek Lee, Ph.D., Program Director</h2><p><strong>Council Date: June 16, 2023</strong></p><h3>Purpose:</h3><p>The purpose of this initiative is to support SBIR grant applications from small business concerns that propose to implement investigator-initiated, early-stage clinical trials with greater than minimal risk and typically are Phase I or II trials. The risk level of the trials supported under this initiative requires appropriate performance oversight and safety monitoring. For purposes of this initiative, the proposed study must be intended to evaluate interventions aimed at screening, diagnosing, preventing, or treating vision disorders.</p><h3>Rationale:</h3><p>NEI accepts clinical trial applications submitted under <a href="https://grants.nih.gov/grants/guide/pa-files/PA-22-177.html">SBIR</a> and <a href="https://grants.nih.gov/grants/guide/pa-files/PA-22-179.html">STTR</a> Omnibus/Parent Clinical Trial Required Notices of Funding Opportunities that include human subjects prospectively assigned to one or more interventions that are minimal risk. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (<a href="https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html">45 CFR 46</a>). However, with the current Omnibus SBIR and STTR funding opportunities, it is difficult to ensure 1) sufficient clinical trial details at the point of application submission, 2) appropriate reviewer expertise on the standing small business review panels, and 3) appropriate performance oversight and safety monitoring, for greater than minimal risk clinical trial projects. Currently, the NEI uses U01 cooperative agreement mechanism <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-22-149.html">PAR-22-149</a> to support early-stage, small-scale clinical trials that are greater than minimal risk; and UG1 Clinical Trial funding opportunities <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-21-041.html">PAR-21-041</a>, <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-21-042.html">PAR-21-042</a>, and <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-21-043.html">PAR-21-043</a> to support large-scale, multi-center clinical trials, human gene-transfer and stem cell therapy trials, and other complex, high resource, or more than minimal risk clinical trials. However, the U01 and UG1 Funding Opportunities are <em>not</em> specifically designed to support expedited (2 or 3 years) and commercialization-oriented trial projects.</p><h3>Objectives and Scope:</h3><p>This initiative will support applications for SBIR clinical trials with the project period of 2 or 3 years, to investigate the safety and/or efficacy of screening, diagnostic, preventative, or therapeutic interventions. This initiative will be specifically intended for early-stage clinical trials with greater than minimal risk, that have strong preliminary and/or pre-clinical data, a well-described Commercialization Plan, and clear delineation of milestones. Applications will be evaluated for scientific and technical merit by a Special Emphasis Panel convened by the NEI. This initiative would fill in an important gap in the NEI Small Business Research Program portfolio and support greater than minimal risk human trials testing particularly in the following relevant areas 1. invasive ocular implants; 2. invasive surgical or diagnostic instruments; and 3. early-stage trials of therapeutic drugs, biologics, and other devices.</p>
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